Sarilumab

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Sarilumab
Mass / length primary structure 143.9 kDa
Drug information
ATC code L04 AC14
Drug class Monoclonal antibodies

Sarilumab (trade name Kevzara ) is a human monoclonal antibody (type IgG1 ) that selectively binds to interleukin-6 receptor-α (IL-6-Rα). It inhibits the action of interleukin-6 (IL-6), which normally binds to the IL-6 receptor. In the European Union , the drug is approved for the treatment of adults with moderate to severe rheumatoid arthritis when treatment with disease-modifying anti- rheumatic drugs ( DMARD ) has not been sufficiently effective or has led to unpleasant side effects. It is used in combination with methotrexate , but can also be used as monotherapy if the patient cannot tolerate methotrexate. It is given subcutaneously every two weeks . Another antibody used to block the effects of IL-6 is tocilizumab .

Side effects

The most common side effects are neutropenia , abnormal liver values, high blood cholesterol, reddening of the skin at the injection site, infections of the nose and throat, and urinary tract infections . The most serious known side effects are severe infection, hypersensitivity reactions, neutropenia, and gastrointestinal perforation. See a doctor immediately if symptoms suggest severe infection or gastrointestinal perforation. As part of the approval process, a patient passport was issued to inform the patient of this.

Clinical studies

COVID-19

Sarilumab is being investigated in clinical trials for the treatment of COVID-19 patients. Interleukin-6 may play a role in the excessive inflammatory response of the body triggered by SARS-CoV-2, which may cause a. affects the lungs of COVID-19 patients. In some of the patients a situation develops in the late phase of the disease that is compatible with a secondary, virus-triggered hemophagocytic lymphohistiocytosis . These patients show massive inflammation . A blockade of the interleukin-6 receptor is discussed as a possible therapeutic approach in this situation.

Uveitis

Sarilumab is being studied for the treatment of non-infectious uveitis .

Individual evidence

  1. ^ National Institute of Diabetes and Digestive and Kidney Diseases: Sarilumab . In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda, MD, 2012-2017. PMID 31643297 .
  2. a b E. B. Lee: A review of sarilumab for the treatment of rheumatoid arthritis. In: Immunotherapy. Volume 10, number 1, 01 2018, pp. 57-65, doi : 10.2217 / imt-2017-0075 , PMID 29043871 .
  3. EG Boyce, EL Rogan, D. Vyas, N. Prasad, Y. Mai: Sarilumab: Review of a Second IL-6 Receptor Antagonist Indicated for the Treatment of Rheumatoid Arthritis. In: The Annals of pharmacotherapy. Volume 52, number 8, 08 2018, pp. 780-791, doi : 10.1177 / 1060028018761599 , PMID 29482351 .
  4. Kevzara - SUMMARY OF MEDICINAL PRODUCT CHARACTERISTICS. Retrieved April 10, 2020 .
  5. ^ YN Lamb, ED Deeks: Sarilumab: A Review in Moderate to Severe Rheumatoid Arthritis. In: Drugs. Volume 78, Number 9, June 2018, pp. 929-940, doi : 10.1007 / s40265-018-0929-z , PMID 29931592 .
  6. ^ A. Ogata, Y. Kato, S. Higa, K. Yoshizaki: IL-6 inhibitor for the treatment of rheumatoid arthritis: A comprehensive review. In: Modern rheumatology. Volume 29, number 2, March 2019, pp. 258-267, doi : 10.1080 / 14397595.2018.1546357 , PMID 30427250 .
  7. Kevzara - EPAR summary for the public. European Medicines Agency, 2017, accessed April 10, 2020 .
  8. Summary of the Risk Management Plan (RMP) for Kevzara® (sarilumab). Sanofi-Aventis (Suisse), February 27, 2018, accessed on April 10, 2020 (English).
  9. Important information about KEVZARA®: Officially ordered training material (patient pass). Sanofi-Aventis Deutschland GmbH, August 2017, accessed on April 10, 2020 .
  10. Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19 - Full Text View - ClinicalTrials.gov. Retrieved April 12, 2020 (English).
  11. Sarilumab COVID-19 - Full Text View - ClinicalTrials.gov. Retrieved April 12, 2020 (English).
  12. Paul Ehrlich Institute - Reports - Therapy against COVID-19 symptoms in development - clinical trial of sarilumab approved. Retrieved April 12, 2020 .
  13. Information on the detection, diagnosis and therapy of patients with COVID-19. Permanent working group of the competence and treatment centers for diseases caused by highly pathogenic pathogens at the Robert Koch Institute, April 8, 2020, accessed on April 12, 2020 .
  14. S. Karkhur, M. Hasanreisoglu, E. Vigil, MS Halim, M. Hassan, C. Plaza, NV Nguyen, R. Afridi, AT Tran, DV Do, YJ Sepah, QD Nguyen: Interleukin-6 inhibition in the management of non-infectious uveitis and beyond. In: Journal of ophthalmic inflammation and infection. Volume 9, number 1, September 2019, p. 17, doi : 10.1186 / s12348-019-0182-y , PMID 31523783 , PMC 6745304 (free full text).